On August 15, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage U.S.-China oncology drug development company, reported that it has filed an application with the U.S. Food and Drug Administration ("U.S. FDA") seeking Fast-Track designation for its drug candidate abexinostat as a monotherapy for the treatment of relapsed or refractory follicular lymphoma ("r/r FL") (Press release, Xynomic Pharmaceuticals, AUG 15, 2019, View Source [SID1234538777]).

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Fast-Track designation is designed to aid in the development and expedite the review of drug candidates, which show promise in treating a serious or life-threatening disease, and address an unmet medical need. A drug candidate that receives Fast-Track designation is eligible for more frequent meetings and correspondences with the U.S. FDA and potential accelerated or priority review and more. The U.S. FDA will review the request and attempt to make a decision within 60 days.

According to Cancer.net, follicular lymphoma is the second most common form of lymphoma in the U.S. and Europe. Xynomic is conducting a Phase 2 trial to test abexinostat as a single agent in patients with r/r FL. Designed as a single arm trial, this trial will enroll approximately 120 patients in the U.S. and Europe who have undergone at least three lines of therapy to test abexinostat as a fourth line monotherapy.

The U.S. FDA has already granted Fast-Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of renal cell carcinoma ("RCC"). A global, randomized pivotal Phase 3 trial is underway to test abexinostat combined with pazopanib as a first- or second-line therapy in patients with locally advanced or metastatic RCC.

About Xynomic Pharmaceuticals Holdings, Inc.
Xynomic Pharmaceuticals Holdings, Inc. is a clinical stage oncology-focused biopharmaceutical company. Its current pipeline mainly consists of 3 drug candidates; Xynomic owns global exclusive development, manufacturing and commercialization rights to each of these. Its lead drug candidate abexinostat is in global potentially pivotal clinical trials against renal cell carcinoma (in combination with pazopanib) and non-Hodgkin’s lymphoma (as a single agent). Xynomic’s XP-105 (BI 860585) is a Phase 2 ready, ATP-competitive mTORC1/2 inhibitor against solid tumors. Xynomic’s XP-102 (BI 882370) is a Phase 1 ready pan-RAF inhibitor.

Use of Forward-Looking Statements

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On August 15, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that is has entered into a research collaboration with the Helmholtz Zentrum München (Press release, Phio Pharmaceuticals, AUG 15, 2019, View Source [SID1234538776]). The agreement covers the design and development of new targets based on Phio Pharmaceuticals’ proprietary self-delivering RNAi platform for use in cancer immunotherapies. This work will be performed at the Immunoanalytics Core Facility & research group under leadership of Prof. Dr. Elfriede Nößner and will complement Phio Pharmaceuticals’ internal research and development activities and collaborations with various other academic and industry partners.

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Dr. John A. Barrett, Chief Development Officer of Phio Pharmaceuticals, stated: "We are excited to be working with Dr. Nößner and her team who are experts in the study of lymphoid and myeloid effector cells and how to improve their contribution in overcoming tumor immunosuppression. In addition, the group has a successful track record of industry collaborations, thus the work will be of direct relevance for the development of the next generation therapeutics based on our self-delivering RNAi platform."

Prof. Dr. Elfriede Nößner, Head of Immunoanalytics at the Helmholtz Zentrum München, said: "Available data shows that Phio Pharmaceuticals’ self-delivering RNAi technology is ideally suited to inhibit checkpoints in immune effector cells such as T cells and NK cells in the microenvironment of solid tumors or inflammatory diseases. I look forward to working with the Phio team on targets beyond their interesting checkpoint-inhibiting self-delivering RNAi pipeline."

On August 15, 2019 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2019 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 15, 2019, View Source [SID1234538775]).

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"Throughout the second quarter we continued to execute on our clinical development plans for our innovative RNAi nanoparticle therapeutics. We are excited to begin dosing patients in the amended cohorts of our Phase 2 study of prexigebersen, which will first evaluate the safety of prexigebersen in combination with decitabine in untreated AML and high risk MDS patients and refractory/relapsed AML and high risk MDS patients, and then evaluate the efficacy of the triple combination of prexigebersen + decitabine + venetoclax in those patient groups," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

"We are also looking forward to completing Investigational New Drug (IND) enabling studies of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor for the treatment of pancreatic cancer, and to file an IND application for a Phase 1 study of BP1003 for the treatment of pancreatic cancer in 2020. We are particularly excited to launch this program as it will be our first-in-human validation of this cutting-edge therapy in an especially challenging cancer indication that has limited treatment options," added Mr. Nielsen.

Recent Corporate Highlights

Presented Preclinical Data at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. In April 2019, Bio-Path presented data from preclinical studies supporting the potential of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and acute myelogenous leukemia (AML). These data were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA.
Financial Results for the Second Quarter Ended June 30, 2019

The Company reported a net loss of $2.5 million, or $0.87 per share, for the three months ended June 30, 2019, compared to a net loss of $1.7 million, or $2.96 per share, for the three months ended June 30, 2018.

Research and development expenses for the three months ended June 30, 2019 increased to $1.5 million, compared to $0.8 million for the three months ended June 30, 2018 primarily due to the commencement of activities related to Stage 2 of our Phase 2 clinical trial in AML to include venetoclax combination treatment with prexigebersen and two cohorts of patients.

General and administrative expenses for the three months ended June 30, 2019 increased to $1.0 million, compared to $0.9 million for the three months ended June 30, 2018 primarily due to increased legal fees and insurance costs.

As of June 30, 2019, the Company had cash of $17.1 million, compared to $1.0 million at December 31, 2018. Net cash used in operating activities for the six months ended June 30, 2019 was $4.2 million compared to $3.4 million for the comparable period in 2018. Net cash provided by financing activities for the six months ended June 30, 2019 was $20.3 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2019 financial results and to provide a general update on the Company. To access the conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to conference ID 3792557. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On August 15, 2019 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.53 per share, payable on October 21, 2019 to shareholders of record of Quest Diagnostics common stock on October 4, 2019 (Press release, Quest Diagnostics, AUG 15, 2019, View Source [SID1234538773]).

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On August 15, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that Janssen Biotech, Inc. (Janssen) will present data from a Phase I clinical study of ADC-1013 (JNJ-7107) at the upcoming ASCO (Free ASCO Whitepaper) Annual meeting held in Chicago on May 31- June 4 (Press release, Alligator Bioscience, AUG 15, 2019, View Source [SID1234538665]). The study results show that side effects were generally mild and transient.

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The primary aim of the study was safety and to establish a recommended dose for Phase II. The study is still ongoing and has enrolled a total of 95 patients. The maximum tolerated dose has not yet been reached. Doses up to 1200 μg/kg i.v without premedication, and up to 2000 μg/kg with premedication have been shown to be safe and tolerable. Early evidence of clinical activity in this study included a partial response (PR) in a patient with renal cell cancer and 10 patients with prolonged stable disease (SD) ≥6 months.

"I am glad to see the promising safety and tolerability profile of ADC-1013 in patients with cancer. This together with the early signs of clinical activity, gives me great confidence in this CD40 drug candidate", said Per Norlén, CEO of Alligator Bioscience.

A poster (#171) with the title "A Phase 1 Study to Assess Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of JNJ-64457107, a CD40 Agonistic Monoclonal Antibody, in Patients (pts) with Advanced Solid Tumors" will be showcased at ASCO (Free ASCO Whitepaper) on June 1, 2019 from 8 – 11 a.m. in the session Developmental Immunotherapy and Tumor Immunobiology.

The licensing agreement with Janssen encompasses milestone payments up to a potential total value of USD 695 million. Alligator is also eligible to receive tiered royalties on worldwide net sales upon successful launch and commercialization of ADC-1013.

For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 11:00 p.m. CEST (5:00 p.m. ET) on May 15, 2019.

About ADC-1013 (JNJ-7107)
ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Results from a previous clinical Phase I first-in-human study performed by Alligator (International Journal of Cancer, View Source) showed that ADC-1013 was generally well tolerated. Preclinical data have previously shown that the ADC-1013 antibody effectively activates T cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T cell activation enables the immune system to attack the cancer.